Guide wire loading method and apparatus with towel attachment mechanism and retaining member

ABSTRACT

A device for loading a guide wire into the open end of a tubular instrument, such as a catheter. The device can be a block of material having a groove in its surface. The ends of the guide wire and the tubular instrument are placed into the groove and moved toward each other. When the ends meet, the groove guides the guide wire into the open end of the tubular instrument. The groove, or at least a portion of the groove, can have a cross-sectional contour that closely matches the outside radius of the tubular instrument. The groove can have a substantially vertical wall and a substantially non-vertical wall. A variety of attachment mechanisms may be provided for attaching the device to a towel draping a patient. A retaining member is disposed on the surface of the device for retaining a guide wire or tubular instrument against movement.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 12/498,965, filed Jul. 7, 2009, entitled “Guide Wire LoadingMethod and Apparatus with Towel Attachment Mechanism”, which is acontinuation-in-part of U.S. patent application Ser. No. 12/218,031,filed Jul. 9, 2008, entitled “Guide Wire Loading Method and Apparatus.”This application is also a continuation-in-part of U.S. patentapplication Ser. No. 12/498,985, filed Jul. 7, 2009, entitled “GuideWire and Catheter Management Device”, which is a continuation-in-part ofU.S. patent application Ser. No. 12/217,852, filed Jul. 8, 2008,entitled “Guide Wire and Catheter Management Device”. The entirety ofeach of the applications listed above is incorporated by referenceherein.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not Applicable

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention is in the field of equipment used for intravascularmedical procedures, such as guide wires, stents, angioplasty balloons,drilling burrs, and the catheters that are used to convey some of these.

2. Background Art

In the field of interventional cardiology, catheters and other tubularinstruments are often run into a blood vessel by being threaded over aguide wire that has been placed into the blood vessel. So, it is oftennecessary to thread a very small diameter guide wire into the open endof a very small tubular instrument. The guide wires are usually about0.014 inches in diameter, and the tubular instruments into which theyare threaded can have diameters ranging from about 2 to 4 French.Catheters are often used to convey and operate various other types ofinstruments, such as balloons, stents, burrs, or radioactive segments.Many of these are also tubular in shape, and guide wires are oftenthreaded through them. Because of the small diameters of the catheters,these other instruments, and the guide wires, it is very difficult tosee and manipulate these members well enough to thread the guide wireinto the tubular instrument very quickly. The speed and efficiency ofevery movement are important in interventional cardiology and otherdisciplines, as the blood flow in the blood vessel being used is oftencompromised.

It is the object of the present invention to provide a device, and amethod for its use, which will quickly and efficiently thread a verysmall diameter guide wire into a very small diameter tubular instrument,such as a catheter. It is also an object of the present invention toprovide a device for threading a guide wire into a tubular instrumentthat can be conveniently secured in place to an operating field.

BRIEF SUMMARY OF THE INVENTION

The present invention is a device for loading a guide wire into the openend of a tubular instrument such as a catheter. The device can be ablock of material which has an open groove in its surface. The end ofthe guide wire and the open end of the tubular instrument are placedinto the groove, and the two ends are moved toward each other. The guidewire and the tubular instrument can be angled above the device, withjust their ends touching the groove and moving along the groove. Whenthe ends meet, the groove guides the guide wire into the open end of thetubular instrument.

The groove, or at least a portion of the groove, can have across-sectional contour that closely matches the outside radius of thetubular instrument. The bottom of the groove is basically a concavesurface. The bottom of the groove can have a radiused or roundedcross-sectional contour, or it can be formed by a plurality ofsubstantially flat longitudinal surfaces intersecting at shallow angles(e.g., between about 125 degrees and 175 degrees), thereby approximatinga rounded contour. In this case, the spaces created by the jointsbetween the flat surfaces, between the groove surface and the catheter,must be small enough to prevent entry of the end of the guide wirebetween the catheter and the groove surface. In another implementation,the angles of the groove walls are not symmetric; while one may bevertical to arrest the guide wire and/or tubular instrument againstlateral movement, the other may be angled to allow the guide wire and/ortubular instrument to be inserted more easily into the device. In anycase, the radius and depth of the rounded or multi-surfaced contour canbe sized to work best with any selected diameter of tubular instrument.

The groove can have a uniform depth and cross-sectional radius along itsentire length. The groove also can be split into two end-to-endsegments, with one segment or portion having a shallower depth, and/or asmaller radius, than the other segment or portion, thereby forming adiscontinuity in the depth, and/or the radius, of the groove where thetwo portions meet. In this case, the guide wire is run in the shallower,and/or smaller radiused, portion of the groove, and the tubularinstrument is run in the deeper, and/or larger radiused, portion.Preferably, the tubular instrument would first be run along the deeper,and/or larger radiused, portion of the groove until it butts up againstthe discontinuity in depth, and/or radius, where the two portions of thegroove meet. Then, the guide wire would be run along the shallower,and/or smaller radiused, portion of the groove until its end enters theopen end of the tubular instrument.

The device also can have a plurality of grooves on its surface, witheach groove having a different depth, and/or cross-sectional radius, tomake it substantially match the radius of a different diameter tubularinstrument. Each groove can be labeled as to the size of tubularinstrument with which it can best be used. Grooves having two differentdepths, and/or cross-sectional radii, can be so labeled.

The inner surface of the groove can have a slick surface, either becauseof the material from which the device is formed, the smoothness of thesurface, or because of lubrication on the surface.

The device may have one or more attachment mechanisms to allow the sameto be secured in an operating field onto, e.g., a fabric such as a toweldraping a patient. The attachment mechanisms may be of a number of typesof construction, and may include towel clamps with springs or clips,flexible fork assemblies, flexible tabs, hinged tabs, wire capturesystems, gripping ring with flexible fingers, wire-and-plug capturesystems, and opposing finger towel capture systems.

The device may have a retaining member formed thereon, the retainingmember to act like a person's hand to hold a guidewire wire in place asone is advancing a catheter through a guide catheter, into the body.After using one of the two grooves to load the catheter on to the guidewire, the operator advances the catheter, e.g., a rapid exchangeguidewire, along the wire until the end of the wire exits the side ofthe catheter. This exit point is typically about 20 cm proximal to thedistal catheter tip. The second operator (the assistant) then slides theend of the wire into the retaining member where it is held firmly inplace. This second operator (the assistant) is no longer required tohold the wire in place and is now free to perform other actions.

The novel features of this invention, as well as the invention itself,will be best understood from the attached drawings, taken along with thefollowing description, in which similar reference characters refer tosimilar parts, and in which:

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

FIG. 1 is a perspective view of a device according to the presentinvention, in use with a guide wire and a catheter;

FIG. 2 is a sectional view of one type of cross-sectional contour thatmay be used in the invention of FIG. 1;

FIG. 3 is a sectional view of a second type of cross-sectional contourthat may be used in the invention of FIG. 1;

FIG. 4 is a perspective view of a second embodiment of a deviceaccording to the present invention;

FIG. 5 is a perspective view of the embodiment of FIG. 4 in use with aguide wire and a catheter;

FIG. 6 is a perspective view of a third embodiment of a device accordingto the present invention;

FIG. 7 is a cross-sectional view of a groove, illustrating a bottomprofile consisting of vertical sides culminating in a rounded contour;

FIG. 8 is a cross-sectional view of another groove, illustrating abottom profile consisting of one vertical side and one non-vertical sideculminating in a rounded contour;

FIGS. 9(A) and 9(B) are perspective and side views, respectively, of afirst embodiment of an attachment mechanism for attaching a device to atowel, e.g., as may be draping a patient during surgery, hereimplemented as a towel clamp with spring;

FIGS. 10(A) and 10(B) are perspective and side views, respectively, of asecond embodiment of an attachment mechanism for attaching a device to atowel, e.g., here implemented as a towel clamp with clip;

FIGS. 11(A) and 11(B) are perspective and side views, respectively, of athird embodiment of an attachment mechanism for attaching a device to atowel, e.g., here implemented as a flexible fork assembly, which may beemployed with or without a spring;

FIGS. 12(A) and 12(B) are perspective and side views, respectively, of afourth embodiment of an attachment mechanism for attaching a device to atowel, e.g., here implemented as a flexible tab assembly;

FIGS. 13(A) and 13(B) are perspective and side views, respectively, of afifth embodiment of an attachment mechanism for attaching a device to atowel, e.g., here implemented as a hinged cover with a snap-buttonassembly;

FIGS. 14(A) and 14(B) are perspective and side views, respectively, of asixth embodiment of an attachment mechanism for attaching a device to atowel, e.g., here implemented as a sliding wire capture lock;

FIGS. 15(A) and 15(B) are perspective and side views, respectively, of aseventh embodiment of an attachment mechanism for attaching a device toa towel, e.g., here implemented as a gripping ring with flexiblefingers;

FIGS. 16(A) and 16(B) are perspective and side views, respectively, of aeighth embodiment of an attachment mechanism for attaching a device to atowel, e.g., here implemented as a capture wire with engagement buttonassembly; and

FIGS. 17(A) and 17(B) are side and perspective views, respectively, of aninth embodiment of an attachment mechanism for attaching a device to atowel, e.g., here implemented as sets of opposing fingers. In thesefigures, as well, an implementation of the device is shown, having twogrooves without abutments and six grooves with abutments and roundedends, for threading guide wires through certain catheters having roundedends.

FIGS. 18(A)-18(D) illustrate top, perspective, side, and side sectionalviews of a device for loading and retaining guide wires and tubularmembers such as catheters.

FIGS. 19(A)-19(C) illustrate side sectional, perspective, and top viewsof a retaining member that may be employed in the embodiment of FIGS.18(A)-18(D).

DETAILED DESCRIPTION OF THE INVENTION

As shown in FIG. 1, a device 10 according to the present inventioncomprises a body 11, also termed a housing, made of any appropriatematerial, such as a plastic or metal. Formed within at least one surfaceof this body 11 is at least one open groove 12. Generally the groove isformed on a top surface of the body or housing. Various possiblecharacteristics of the groove 12 are discussed below. In use, a guidewire GW has been introduced into a blood vessel of a patient (notshown). The free end FE of the guide wire GW is placed in the groove 12.The guide wire is held so that it is angled relative to the surface ofthe body 11, for example, at a 45 degree angle, as its free end FE isplaced and held in the groove 12. A selected catheter SC is also held sothat it is angled at a similar angle relative to the surface of the body11, oriented toward the groove 12, and an open end OE of the catheter SCis placed in the groove 12. Rather than a catheter, any other type oftubular instrument may also be used with the present invention. Thecatheter, or any other tubular instrument for that matter, is referredto herein as a “selected” catheter, because it is selected for use inthe medical procedure, at least partially because of its outsidediameter. The groove 12 is designed to have dimensions that willfunction best with this selected outside diameter of the selectedcatheter SC. Once the respective ends FE, OE of the guide wire GW andthe selected catheter SC are placed within the groove 12, the guide wireGW and the catheter SC are moved toward each other. Alternatively, onemember may be held stationary, and the other member may be moved towardit. What matters is that the ends FE, OE of the two members are broughttogether in the groove 12. When the two ends FE, OE meet, the free endFE of the guide wire GW will enter the open end OE of the catheter SC,with both being guided by the groove 12.

It is usually helpful if the surface of the groove 12 is made “slick”,either by being made very smooth, or by being lubricated, or both. Inorder to achieve lubrication, the body 11 of the device 10 may be formedof a lubricious material, such as various types of plastic, orlubrication can be provided by application of a lubricant in the groove12 or on the guide wire GW. Application of a liquid to the groove 12 mayalso be beneficial, in that the surface tension of the liquid may assistin guiding the guide wire GW into the selected catheter SC.

The groove 12 may have several different types of cross section andvarious depths. As shown in FIG. 1, the groove 12 may be substantially asemi-circular groove in the surface of the body 11. Alternatively, asshown in FIG. 2, the groove 12 may have sides 13 that taper inwardlytoward a substantially concave cross-sectional contour 14 at the apex,or bottom, of the tapered groove 12. In FIG. 2, the concave contour isactually rounded, having a radius that substantially matches the outsideradius of the catheter SC. It can also be seen that, while in FIG. 1,the groove 12 has a depth that is less than the outside diameter of thecatheter SC, FIG. 2 shows that the groove 12 can alternatively havedepth that is greater than the outside diameter of the catheter SC.

FIG. 3 illustrates that, rather than having a rounded cross-sectionalcontour, the concave contour 14 at the bottom of the groove 12 can alsobe formed by a plurality of other surfaces, such as longitudinallyarranged substantially flat surfaces 15 within the groove 12, with theflat surfaces forming a contour approximating a radiused curve. It isimportant that the spaces created by the joints between the flatsurfaces, between the groove surface and the catheter, must be smallenough to prevent entry of the end of the guide wire between thecatheter and the groove surface. That is, the flat surfaces must besufficiently narrow, and appropriately angled, to insure that the spacebetween the flat groove surfaces and the catheter is less than thediameter of the guide wire. FIG. 3 also shows that this approximateradiused curve can also have a radius that substantially matches theoutside radius of the catheter SC. Whether the concave contour 14 isround or formed from a plurality of flat surfaces, it is preferred thatthe concave contour 14 have a radius that is substantially the same asthe outside radius of the catheter SC, plus or minus 10% of the catheterradius. Ideally, the concave contour 14 will have a radius that is noless than the outside radius of the catheter SC, and no greater than theoutside radius of the catheter SC plus 10% of the catheter radius.

As shown in FIG. 4, the groove 12 can have two segments or portions 16,17, with a first segment 16 having a shallower depth and/or a smallerradius than the second segment 17. This forms a discontinuity 18 at thepoint where the two groove portions 16, 17 meet, end-to-end. At thediscontinuity 18, the depth and/or radius of the groove 12 change fromthe shallower depth and/or smaller radius of the first portion 16 to thedeeper depth and/or larger radius of the second portion 17. It is alsousually advantageous to have the center of radius, or axis, of the firstportion 16 of groove 12 aligned with the center of radius, or axis, ofthe second portion 17 of the groove 12. FIG. 5 shows this embodiment ofthe invention 10 in use. First, the open end OE of the selected catheterSC is placed in the second portion 17 of the groove 12, and the open endOE of the selected catheter SC is slid along this deeper/larger radiusedportion 17 of the groove 12, until the open end OE abuts thediscontinuity 18. Then, the free end FE of the guide wire GW is placedin the first portion 16 of the groove 12, and the free end FE of theguide wire GW is slid along this shallower/smaller radiused portion 16of the groove 12, until the free end FE of the guide wire GW enters theopen end OE of the selected catheter SC. In some applications, havingthis disparity between the depths and/or radii of the two portions 16,17 of the groove 12 makes it easier to thread a guide wire GW into aselected catheter SC, or some other tubular instrument.

FIG. 6 illustrates that the device 10 can have a plurality of opengrooves 12 in the body 11. Each of the grooves 12 can be formed with adifferent depth and/or a different radius on its bottom contour. Somegrooves 12 may have discontinuities 18, and others may be continuous.Each groove 12 should have a label 19 which can indicate the depth,bottom contour shape, or radius of the groove, as well as whether thegroove 12 is continuous or has a discontinuity 18.

It has been found that the present invention functions in an optimumfashion if the shape of at least the catheter portion of the groove 12has certain specific characteristics. While these characteristics arenot critical to the invention, they add to its functionality.Specifically, as shown in FIG. 7, the groove 12 can have a bottomprofile consisting of vertical sides 20 culminating in a rounded contour21. The upper profile consists of sloped sides 22 that taper inwardlyfrom the surface of the body 11 toward the upper ends of the verticalsides 20. The rounded contour 21 has a diameter that is the same as theouter diameter of the catheter SC. As a result, this rounded contour 21makes full contact with a 180 degree radius of the periphery of thecatheter SC, thereby gripping the catheter SC securely, but not impedingplacement of the catheter SC into the groove 12. The vertical sides 20extend upwardly from there. The full depth of the bottom profile of thegroove 12, including the vertical sides 20 and the rounded contour 21,is approximately twice the diameter of the selected catheter SC. Thesloped sides 22 assist in placing the catheter SC into the bottomprofile 20, 21 of the groove 12.

FIG. 8 illustrates another implementation in which the shape of thecatheter and/or guide wire portion of the groove affords an optimumfunctionality. As with FIG. 7, implementing such shapes is not criticalto the invention. As shown in FIG. 8, a groove 28 can have a bottomprofile consisting of a substantially vertical wall 26 and asubstantially non-vertical wall 32 culminating in a rounded contour 23.This profile may be considered an “eccentric” one due to the asymmetryof the walls. It should be noted that while the wall 26 is termed a“vertical” wall, it need not be exactly vertical—rather a small anglemay be instituted in the wall, and the wall should still be consideredsubstantially vertical. The substantially vertical wall and thesubstantially non-vertical wall may form an angle of between about 10degrees and 50 degrees. While not shown in FIG. 8, but in the same wayas in FIG. 7, the upper profile may further include sloped sides thattaper inwardly from the surface of the body toward the upper end of thevertical side and the upper end of the non-vertical side. The roundedcontour 23 may have a diameter that is substantially the same as theouter diameter of the catheter SC. As a result, this rounded contour 23generally makes less than a 180-degree contact with the periphery of thecatheter SC, thereby still gripping the catheter SC securely, but makingplacement of the catheter SC into the groove 28 even easier. Forexample, the angular segment over which contact is made may be betweenabout 90 degrees and 180 degrees, and especially between about 90 degreeand 120 degrees. In this way, the rounded contour makes substantialcontact with the outer diameter of the catheter SC, while still allowingparticularly convenient placement of the catheter SC into the groove 24.

As before, the full depth of the bottom profile of the groove 28,including the vertical and non-vertical sides 26 and 32 respectively,and the rounded contour 21, is approximately twice the diameter of theselected catheter SC.

Devices such as the kind described above are often located at, in, ornear the surgical operating field. In fact, it is often highlyconvenient to locate them very close to the catheter insertion location.Accordingly, they may often be placed on the patient or adjacent thepatient. During surgery, a patient is typically draped with multipletowels, leaving only the actual sterile field exposed. For this reason,it is desirable to be able to secure the device to one of these towels.

FIGS. 9(A) and 9(B) are perspective and side views, respectively, of afirst embodiment of an attachment mechanism for attaching a device to atowel, e.g., as may be draping a patient during surgery, hereimplemented as a towel clamp with spring. In particular, a device 10 isillustrated that has a construction as described above. The device 10 ismounted to or formed integrally with an attachment mechanism, which inthis case is a towel clamp with spring assembly 34. The towel clamp withspring assembly 34 includes an upper plate 36 and a lower plate 38 whichare attached via a hinge assembly 44 which may include a spring 46. Apull tab 42 may extend from one extremity of the upper or lower plate(or both) for ease in attaching (and disengaging) the towel clamp from atowel T.

In use, a towel T is placed between the upper and lower plates. Thespring forces the upper plate towards the lower one, frictionallysecuring the device 10 to the towel T. At any time, for installation orfor removal, the pull tab 42 may be used to separate the upper from thelower plate.

FIGS. 10(A) and 10(B) are perspective and side views, respectively, of asecond embodiment of an attachment mechanism for attaching a device to atowel, e.g., here implemented as a towel clamp with clip. In particular,a device 10 of the above-described construction is mounted on or formedintegrally with an attachment mechanism, shown in FIGS. 10(A) and 10(B)as a towel clamp with clip 41. Some elements are the same as in FIG. 9.For example, an upper plate 36 is coupled to a lower plate 38, and apull tab 42 may extend from either (in FIGS. 10(A) and 10(B), from theupper plate). A hinge assembly 44 allows hinged movement of the plates.However, one of ordinary skill will recognize that the hinge assembly 44is not necessary in all of these embodiments. For example, in FIGS.10(A) and 10(B), the clip itself, as described below, may in someconstructions be enough to hold the upper plate attached to the lowerplate.

Referring again to FIGS. 10(A) and 10(B), a clip 48 is shown, whichholds the upper plate to the lower plate. The clip 48 may ride in anoptional track 49 for ease of placement. An internal slot 54 may also beemployed such that the clip 48 has a lower arm 51 that enters the lowerplate. The internal slot 54 is only shown in FIG. 10(B). It will berecognized that the track or internal slot may be employed on either theupper or lower plates, or both. However, in many implementations, it iseasier to remove the clip if at least one plate does not employ aninternal slot. For additional ease of installation and removal, acorrugation 52 may be disposed on an upper arm 47 of the clip 48.

For installation, a towel T is placed between the upper and the lowerplates and the clip loaded into the track and/or internal slot (or justaround the plates if neither a slot nor a track is employed). Forceapplied in the direction F1 secures the clip to the plates, and thissecures the device 10 to the towel T.

FIGS. 11(A) and 11(B) are perspective and side views, respectively, of athird embodiment of an attachment mechanism for attaching a device to atowel, e.g., here implemented as a flexible fork assembly. Inparticular, FIG. 11 shows a flexible fork assembly 56, which may beemployed with (FIG. 11(A)) or without (FIG. 11(B)) a spring.

At least two tines 58 and 58′ may form the fork 56. One or more taperedsurfaces 60 and 60′ may be employed to ease introduction of the towelportion into a hole 62 defined by the tines 58 and 58′.

In the implementation of FIG. 11(A), in use, the flexibility of thetines themselves may be configured to be enough to, upon installation ofa towel portion, distend the tines and then bring the same back togetherto securely hold a towel.

In a related implementation, that of FIG. 11(B), a flexible forkassembly 56′ is shown including a spring 64 attached to the tine 58. Ina related implementation, a spring may be attached to the tine 58′ aswell. In these implementations, the flexibility of the fork tines isassisted by the angular resilience of the spring.

In use, a towel portion may be inserted into hole 62, and the same maybe conveniently inserted through the use of tapered surfaces 60 and 60′.Generally, a sufficiently-large portion of the towel is inserted so thata sufficient friction-fit is achieved, such that the towel does not pullout of the hole. This requirement can also be employed to set theminimum spring constant (or stiffness) of the spring 64, inimplementations where this element is used.

FIGS. 12(A) and 12(B) are perspective and side views, respectively, of afourth embodiment of an attachment mechanism for attaching aguide-wire-loading device to a towel, e.g., here implemented as aflexible tab assembly 64. While the guide-wire-loading device is notshown in the figure, the same may be mounted on, coupled to, or formedintegrally with the attachment mechanism. The flexible tab assembly 64includes at least two tines 66 and 66′ as well as a flexible tab 68. Aburr 70 may be formed on the flexible tab 68 to allow an enhancedgripping effect on a towel portion T. As shown in FIG. 12(B), a towelportion T may be gathered and forced between the tines 66 and 66′ andunder the flexible tab 68. In this way, a towel may be secured in theflexible tab assembly 64, and thus the guide wire-loading device may besecured to a towel T. To release the towel, a force in the direction F2may be exerted on the flexible tab 68.

FIGS. 13(A) and 13(B) are perspective and side views, respectively, of afifth embodiment of an attachment mechanism for attaching a guidewire-loading device to a towel, e.g., here implemented as a hinged coverwith a snap-button assembly 74. In particular, two opposing segments 76and 76′ define a hole 78 into which a towel (not shown) may be drawn.The hole 78 is shown as substantially circular, but the shape is notcritical. The segments 76 and 76′ may include respective taperedsurfaces 80 and 80′ to ease introduction of a towel into the hole 78. Ahinged cover 82 is shown, which is attached to the segments 76 and 76′by a hinge 88. A neck 86 extends from the cover 82, and a snap button 84is attached to the neck 86.

When a towel portion has been pulled through the hole 78, the cover 82may be closed in the direction indicated by arrow F3. This actionsecures the towel in the hole 78 and thus secures the guide wire-loadingdevice to the towel. In one implementation, as shown, the snap button 84has a bulbous shape; this shape assists in the securing of the snapbutton within the hole. However, other shapes may also be employed. Forremoval, the user may pull up on the cover 82 to pull the snap button 84out of engagement with the hole 78.

FIGS. 14(A) and 14(B) are perspective and side views, respectively, of asixth embodiment of an attachment mechanism for attaching a device to atowel, e.g., here implemented as a sliding wire capture lock 90. Asabove, the same may be coupled to or formed integrally with a guidewire-loading device 10. The sliding wire capture lock 90 includes ahousing 91 in which are formed two slots 100 and 100′. A sliding wire 92includes two longitudinal segments 94 and 94′ which slide in therespective slots 100 and 100′. A cross segment 96 connects segments 94and 94′. A tab 98 may be formed on the cross segment 96, to allow easeof pushing during installation and ease of pulling during removal.Ribbing or other contouring may be employed on one or both sides of thetab 98 to enhance the ability of a user to grip the tab 98 as well as toenhance gripping of a towel portion T.

In use, a towel portion T is placed in the hole formed by segments 94,94′, 96, and the housing 91. The sliding wire 92 is then pushed towardthe housing 91 in the direction indicated by arrow 102 (force F4). Thetowel T is thus captured, and the guide wire-loading device is thussecured to the towel T. For removal, the sliding wire 92 is pulled outin a direction opposite that of installation, and the towel T removed.

FIGS. 15(A) and 15(B) are perspective and side views, respectively, of aseventh embodiment of an attachment mechanism for attaching a guidewire-loading device to a towel, e.g., here implemented as a grippingring assembly 104 with flexible fingers. This assembly 104 includes ahousing 106 coupled to (or as above, integral with) the guidewire-loading device 10 (shown in FIG. 15(B)). A gripping ring 108 isformed in the housing, and the same includes a number of flexiblefingers 108 a, 108 b, and so on. The gripping ring 108 and flexiblefingers 108 i may be formed of, e.g., various plastic or rubbermaterials in order to allow sufficient flexibility to receive a portionof a towel T, secure the same against removal during normal use, andallow the towel to be removed following use. In use, as shown in FIG.15(B), a portion of a towel T may be inserted into the gripping ring.The stiffness of the fingers 108 i prevents removal of the towel untilthe procedure is completed, at which time the towel may be removed.

FIGS. 16(A) and 16(B) are perspective and side views, respectively, ofan eighth embodiment of an attachment mechanism for attaching a guidewire-loading device to a towel, e.g., here implemented as a capture wirewith engagement button assembly 110. The assembly 110 includes twosupports 114 and 114′ to which is mounted a capture wire 116. Thesupports 114 and 114′ are mounted on a housing 113. Also mounted on thehousing 113 is an engagement button 118 via a neck 120.

In use, a towel T is placed over the engagement button 118, and thecapture wire 116 is then moved in an angular direction 112 and placedover the top of the towel T and the engagement button 118. The shape ofthe capture wire 116 and that of engagement button 118 may cooperate tosecure the towel in position, or alternatively the securing may beaccomplished only by way of friction fit with no particular shapesinvolved. To remove, the capture wire 116 is pulled away from the top ofthe engagement button 118, and the towel removed.

FIGS. 17(A) and 17(B) are side and perspective views, respectively, of aninth embodiment of an attachment mechanism for attaching a guidewire-loading device 10 to a towel, e.g., here implemented as an assembly124 of opposing fingers. In these figures, as well, an implementation ofthe device is shown, having two grooves without abutments and sixgrooves with abutments and rounded ends, the latter for threading guidewires through certain catheters having rounded ends.

The device 10 includes a housing 131, and defined within the housing 131is a groove 130 and an eccentric groove 130′. The grooves 130 and 130′may be of the types described above. A flat portion 133 of the housing131 may include protuberances 134 which help to grip the towel andfurther prevent movement of the device 10. The protuberances aregenerally formed on a bottom surface of the housing or body. Mounted toor integral with the device 10 is the assembly 124 of opposing fingers.In FIGS. 17(A) and 17(B), the assembly 124 includes a first finger 122separated by a substantially opposing finger 128. Distal ends of thefingers 122 and 128 are separated by a gap 132. A portion of one or bothfingers 122 and 128 may include ribs 126 for ease in gripping. In thestructure of FIGS. 17(A) and 17(B), only one finger (finger 122) (perset) is shown with ribs 126.

FIG. 17(B) illustrates a perspective view of the attachment mechanism,as well as one implementation of the guide wire-loading device 10. Asmay be seen in both figures, a non-eccentric groove 130 is formed in thedevice, as well as an eccentric groove 130′. A series of variously-sizedgrooves 136 a-136 f are also formed, these including abutments andfeaturing bead-shaped catheter grooves to accommodate devices such asthe Rotablator® noted above. As will be understood, any number of otherconfigurations may be employed as well, depending on the situation. Theuse of the device is as described above.

In use, a towel may be drawn into the gap 132 and held in place byfrictional engagement with fingers 122 and 128. To remove, the gap 132is made larger to allow the towel to escape the frictional engagement.In the configuration of FIGS. 17(A) and 17(B), one way to increase thesize of the gap 132 is to push on the ribs 126, thereby deflecting adistal tip of the finger 122. Other ways of increasing the size of thisgap will also be understood, given this teaching.

In a related embodiment, the guide wire loading device may provide ameans to hold or manage one or more guide wires or catheters. Details ofsuitable means will be understood from U.S. patent application Ser. No.12/498,985, filed Jul. 7, 2009 entitled “Guide Wire and CatheterManagement Device”, incorporated by reference above in its entirety.However, certain details will be discussed below.

Referring to FIG. 18(A)-(D), a guide wire loading device 150 isillustrated including a catheter and guide wire management device 160and a guide wire loading device 170. The guide wire loading device 170is discussed in detail above. The guide wire management device 160 isdiscussed below.

In FIGS. 18(A)-(B) and (D), a retaining member 152 with ribbed slots orgrooves is employed, and the same is inserted into a housing 151.Details of the ribbed retaining member 152 are shown in FIGS.19(A)-19(C). The retaining number 152 includes fingers 172 a and 172 b.The finger 172 a includes a rib 174 a and an indentation 176 a, whilethe finger 172 b is shown with a rib 174 b and an indentation 176 b. Therib 174 a fits into the indentation 176 b while the rib 174 b fits intothe indentation 176 a. In this way, a catheter or guide wire may be heldbetween the ribs and indentations in a secure fashion while minimizingthe effects of ‘healing’, described in greater detail below. Suchretaining members 152 may be conveniently manufactured using an openmold process described in the application noted above and incorporatedby reference, particularly in connection with that application's FIG.5(E).

The retaining member can act like a person's hand to hold a guidewirewire in place as one is advancing a catheter through a guide catheter,into the body. In particular, after using one of the grooves on theguide wire loading device to load the catheter on to the guide wire, theoperator advances the catheter, e.g., a rapid exchange guidewire, alongthe wire until the end of the wire exits the side of the catheter. Thisexit point is typically about 20 cm proximal to the distal catheter tip.The second operator (the assistant) then grabs the end of the wire andinstead of having to maintain that position, holding the wire stablewhile his partner advances the catheter, the second operator slides theend of the wire into the retaining member where it is held firmly inplace. This second operator (the assistant) is now free to perform otheractions.

The materials constituting the retaining member may be, e.g.,elastomeric materials such as a molded rubber or silicone. While theentire shape may be molded, in some implementations, knife slits may bemade into the retaining members to form the surfaces described above.The durometer of the silicone or rubber may vary, e.g., in the range30-80 Shore hardness, although this range is purely exemplary and othervalues are also possible. The materials constituting the housing andattachment mechanisms may be, e.g., an injection-molded plastic,silicone, or rubber. It will be understood that other materials are alsocontemplated.

One aspect important in material choice is ‘healing’, which is thetendency, especially of like materials, to adhere to each other uponconstant contact, e.g., when stored for long periods of time. In theribbed slot examples above, it may be desired to configure the same suchthat the ribs and indentations fit closely but do not touch, even whenwires and catheters are removed. In this way, the amount of deleterious‘healing’ may be lessened. In addition, molded slits may be lesssusceptible to such healing.

Where multiple retaining members are employed, the slits of theretaining members may be such that they are about 1 cm apart, as well as1-2 cm above the operating field, so as to not interfere with thephysician's hand motions. Of course, these distances may vary widelydepending on the application. While the retaining members are describedas generally triangular in shape, it will be understood that any shapewith a similar change in dimensions may be employed, e.g., parabolic orthe like. Retaining members that are only substantially triangular arealso envisioned. As in FIG. 18, retaining members may be used with justone slit or groove, and the entire device may have just one slit orgroove; such embodiments may be particularly useful for temporaryholding of guidewires or the like.

While an exemplary management device 160 has been described as combinedwith the guide wire loading device 170, this management device havingbeen disclosed with respect to FIGS. 8(A)-8(G) of U.S. patentapplication Ser. No. 12/498,985, filed Jul. 7, 2009, entitled “GuideWire and Catheter Management Device”, it will be understood that anymanagement device may be combined with the guide wire loading device170, including those disclosed in FIGS. 1-7 of the above namedapplication, and including those with multiple retaining members. Otherdetails of these management devices will be found in the applicationdisclosed by reference above.

Suitable materials for use in major components of the attachmentmechanisms described above, as well as the device for guide wireloading, include blow- or injection-molded plastics, or the like. Theguide wire-loading device may be single-use disposable or reusable.

While the particular invention as herein shown and disclosed in detailis fully capable of obtaining the objects and providing the advantageshereinbefore stated, it is to be understood that this disclosure ismerely illustrative of the presently preferred embodiments of theinvention and that no limitations are intended other than as describedin the appended claims.

1. A device for loading and managing guide wires and selected tubular instruments having selected outside radii, said device comprising: a body having a flat surface; and at least one open groove formed in the flat surface of said body; an attachment mechanism coupled to the body, the attachment mechanism for securing the body to a fabric; wherein said at least one open groove further comprises: sides that extend within said body and from said flat surface of said body; and a rounded contour at the bottom of said sides, said rounded contour having a cross section with a radius that matches said outside radius of said selected tubular instrument to within plus or minus 10%; further comprising at least one retaining member disposed on the flat surface of the body, the retaining member being adapted to retain at least one flexible elongated member in a selected position.
 2. The device recited in claim 1, further comprising: a plurality of said grooves formed in said body; and a different rounded contour formed in each of at least two of said plurality of grooves, said different contours corresponding to the outside radii of a plurality of different sized selected tubular instruments.
 3. The device recited in claim 2, wherein each said groove in said body has a different rounded contour formed therein.
 4. The device recited in claim 2, further comprising a label associated with each said groove, each said label indicating the outside radius of a selected tubular instrument with which said rounded contour in its associated said groove will match.
 5. The device recited in claim 1, further comprising a smooth surface within said at least one open groove.
 6. The device recited in claim 1, further comprising a lubricant within said at least one open groove.
 7. The device recited in claim 1, wherein: a first portion of said at least one open groove has a shallower depth than a second portion of said at least one open groove; and said first portion of said groove has a first rounded contour with a smaller radius than a second rounded contour in said second portion of said groove.
 8. The device recited in claim 1, wherein the attachment mechanism is selected from the group consisting of: towel clamps with springs or clips, flexible fork assemblies, flexible tabs, hinged tabs, wire capture systems, gripping rings with flexible fingers, wire-and-plug capture systems, at least one protuberance, and opposing finger towel capture systems.
 9. The device recited in claim 8, wherein said first rounded contour in said first portion of said groove has a center of radius which is aligned with a center of radius of said second rounded contour in said second portion of said groove.
 10. The device recited in claim 1, further comprising a housing enclosing said retaining member, and wherein the retaining member has two slots formed therein, and wherein a taper of a first of the two slots is different from a taper of a second of the two slots.
 11. The device of claim 10, wherein the taper of the first slot is configured for a catheter, and wherein the taper of the second slot is configured for a guidewire.
 12. The device recited in claim 1, wherein said sides further comprise: an inwardly tapered section extending from said flat surface of said body; and vertical sides below said inwardly tapered section.
 13. The device recited in claim 12, wherein said vertical sides and said rounded contour of said open groove have a combined depth equal to twice the outside diameter of said selected tubular instrument.
 14. The device recited in claim 1, wherein a cross-sectional shape of at least one of said retaining members is substantially triangular.
 15. The device recited in claim 1, wherein the retaining member has a durometer of between about 30-80 Shore hardness.
 16. The device recited in claim 1, further comprising protuberances disposed on a bottom surface of the housing.
 17. The device recited in claim 10, wherein said first slot includes at least two surfaces forming an angle of between about 2 and 10 degrees.
 18. The device recited in claim 10, wherein said second slot includes at least two surfaces forming an angle of between about 0 and 2 degrees.
 19. The device recited in claim 1, wherein the body includes a bottom surface, and where at least a portion of the bottom surface is curved.
 20. A method for installing a rapid exchange catheter in a patient, said method comprising: attaching a retaining and loading device to a towel draping a patient using an attachment mechanism, the retaining and loading device having a body with a flat surface and having at least one open groove formed within the body and extending into the body from the flat surface, said groove having a concave contour shaped to match an outside radius of said rapid exchange catheter to within plus or minus 10%, and wherein said at least one open groove further comprises sides that extend within the body from said flat surface and a rounded contour at the bottom of said sides; installing a guide wire in a patient; threading a rapid exchange catheter onto the guide wire using the retaining and loading device by: placing an open end of said rapid exchange catheter in said groove; placing an end of said guide wire in said groove; holding said rapid exchange catheter angled above said flat surface of said retaining and loading device, with said open end of said tubular instrument in said groove; holding said guide wire angled above said surface of said retaining and loading device, with said end of said guide wire in said groove; and moving said guide wire and said rapid exchange catheter toward each other, while maintaining said guide wire and said rapid exchange catheter angled above said flat surface, until said end of said guide wire enters said open end of said rapid exchange catheter; securing the guide wire against movement, the securing including retaining the guide wire in a retaining member on the retaining and loading device.
 21. A method for manufacturing a device for wire loading and management, comprising: molding a body having a flat surface with at least one groove formed therein and a housing having at least two vertical supports extending vertically upward from the flat surface; molding a retaining member having a slit or groove defined therein, the molding occurring such that the slit or groove is in a substantially open configuration; and compressing the retaining member and mounting the compressed retaining member between the at least two vertical supports. 